Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Small Cell Lung Carcinoma
Conditions
Keywords
Extensive stage small cell lung cancer, Oligometastasis, Adebrelimab, Chemotherapy, Radiotherapy
Brief summary
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.
Detailed description
Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.
Interventions
DRUGAdebrelimab
Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.
Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
DRUGEtoposide
Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
RADIATIONRadiation therapy
IMRT for thoracic of 45--55Gy in 15-22 fractions，SBRT for metastases during the concurrent chemoradiotherapy phase
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed inform consent form * Age \>= 18 years and \<= 75 years * Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment. * Eastern Cooperative Oncology Group performance status of 0 or 1 * Expected survival time ≥ 3 months * Patients must submit a pre-treatment tumor tissue sample during the study. * Adequate hematologic and end organ function
Exclusion criteria
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization * Leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled or symptomatic hypercalcemia * Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease * Prior treatment with immune checkpoint blockade therapies * Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease. * Significant cardiovascular disease * Prior allogeneic bone marrow transplantation or solid organ transplant * Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization * History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | up to approximately 30 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | up to approximately 30 months |
| Objective Response Rate (ORR) | up to approximately 30 months |
| Disease control rate (DCR) | up to approximately 30 months |
| Percentage of Participants Alive and Without PD at 6 Months and 1 Year | 6 months, 1 year |
| Percentage of Participants Alive at 1 Year and 2 Years | 1 year, 2 years |
| Percentage of Participants with Adverse Events Or Serious Adverse Events | up to approximately 30 months |
| Duration of Response (DOR) | up to approximately 30 months |
Countries
China
Outcome results
None listed